Handbook of Residue Analytical Methods for Agrochemicals VOLUME 1 and VOLUME 2 PDF
Preview Handbook of Residue Analytical Methods for Agrochemicals VOLUME 1 and VOLUME 2
Handbook of Residue Analytical Methods for Agrochemicals VOLUME 1 and VOLUME 2 Editor-in-Chief Dr Philip W Lee DuPont Crop Protection USA Copyright(cid:2)C 2003 JohnWiley&SonsLtd,TheAtrium, SouthernGate,Chichester, WestSussexPO198SQ,England Telephone (+44)1243779777 Email(forordersandcustomerserviceenquiries):[email protected] VisitourHomePageonwww.wileyeurope.comorwww.wiley.com AllRightsReserved.Nopartofthispublicationmaybereproduced,storedinaretrieval systemortransmittedinanyformorbyanymeans,electronic,mechanical,photocopying, recording,scanningorotherwise,exceptunderthetermsoftheCopyright,Designsand PatentsAct1988orunderthetermsofalicenceissuedbytheCopyrightLicensingAgency Ltd,90TottenhamCourtRoad,LondonW1T4LP,UK,withoutthepermissioninwritingof thePublisher.RequeststothePublishershouldbeaddressedtothePermissionsDepartment, JohnWiley&SonsLtd,TheAtrium,SouthernGate,Chichester,WestSussexPO198SQ, England,[email protected],orfaxedto(+44)1243770620. Thispublicationisdesignedtoprovideaccurateandauthoritativeinformationinregardtothe subjectmattercovered.ItissoldontheunderstandingthatthePublisherisnotengagedin renderingprofessionalservices.Ifprofessionaladviceorotherexpertassistanceisrequired, theservicesofacompetentprofessionalshouldbesought. OtherWileyEditorialOffices JohnWiley&SonsInc.,111RiverStreet,Hoboken,NJ07030,USA Jossey-Bass,989MarketStreet,SanFrancisco,CA94103-1741,USA Wiley-VCHVerlagGmbH,Boschstr.12,D-69469Weinheim,Germany JohnWiley&SonsAustraliaLtd,33ParkRoad,Milton,Queensland4064,Australia JohnWiley&Sons(Asia)PteLtd,2ClementiLoop#02-01,JinXingDistripark,Singapore 129809 JohnWiley&SonsCanadaLtd,22WorcesterRoad,Etobicoke,Ontario,CanadaM9W1L1 Wileyalsopublishesitsbooksinavarietyofelectronicformats.Somecontentthatappearsin printmaynotbeavailableinelectronicbooks. WherearticlesintheHandbookofResidueAnalyticalMethodsforAgrochemicalshavebeen writtenbygovernmentemployeesintheUnitedStatesofAmerica,pleasecontactthe publisherforinformationonthecopyrightstatusofsuchworks,ifrequired.Workswrittenby USgovernmentemployeesandclassifiedasUSGovernmentWorksareinthepublicdomain intheUnitedStatesofAmerica. Preface Theagrochemicalindustryis,globally,oneofthemostheavilyregulatedindustries today.Extensiveproductchemistry,environmentalfate,residuechemistry,ecotoxi- cology,andmammaliantoxicologydataarerequiredtosupporttheregistrationand reregistration of all crop protection products. This information is used not only to conducthumandietaryandworkerexposureriskassessmentsbutalsotodetermine thepotentialimpactoftheagrochemicalsandtheirdegradationproducts/metabolites ontheenvironmentandsensitiveecosystems.Thequalityoftheresiduedata,includ- ing the reliability and sensitivities of the analytical methods and the validity of the collectedbiological/environmentalsamples,iscriticaltotheacceptabilityandvalidity oftheriskcharacterization/assessment.Differencesintestingguidelinesbetweenthe variousregulatoryauthoritiesandthelackofstandardizationintestmethodspecifica- tionsfurthercomplicatetheinterpretationandbroadapplicationoftheexposuredata. Significantprogresshasbeenachievedinresidueanalyticaltechnologyinthepast 50years.Today’sresidueanalyticalmethodologydetectsmultipleanalytesroutinely atthenanogramperkilogram(ppt)levelinawidevarietyofsamplematriceswith a high level of selectively and accuracy. The role of the residue analytical chemist is no longer limited to the development and validation of analytical methods but also includes design and conduct of complex field crop residue and environmental monitoring studies. This is a real challenge, especially when studies are conducted underthestrictGoodLaboratoryPracticesguidelines. Recognizing the diverse and rapid growth of residue chemistry as an important scientific discipline, Dr Terry Roberts, Founding Editor of the Handbook of the Residue Analytical Methods of Agrochemicals, organized this publication effort in 1999. The editorial team includes Dr Hiro Aizawa (Hiro Research Consultancy), DrAlBarefoot(DuPontCropProtection)andDrJohnMurphy(BayerCropScience). The scope/objective of this handbook is to present to the reader a comprehensive overview of current global regulatory requirements and the application of various analyticaltechnologies(chromatographicandnon-chromatographic)toresidueanal- ysis.Bestpracticestoconductvariouscropresidueandfieldmonitoringstudiesand detailedmethodproceduresforthedeterminationofmajorclassesofagrochemicals, aswellasindividualcompounds,arekeycomponentsofthishandbook. This handbook consists of two volumes and approximately 80 individual chap- ters.Theeditorialteamacknowledgesthehighqualityofthecontributionsfromthe regulatory,academic,andindustrialresearchersaroundtheworld.Itistheircommit- mentintimeandeffortthatmakethisasuccessfulpublicationproject.Eachchapter wasreviewedbyatleastoneeditorandoftenbyothertechnicalexperts.Theeditorial teamacknowledgesthegenerousadviceandreviewsprovidedbyourcolleaguesfrom DuPontCropProtection(DrWynnJohn,DrChuckPowley)andBayerCorpScience (Dr Lou Russo), the US EPA (Dr Alex Krynitsky) and the USDA ARS (Dr David Smith).Wewouldalsoappreciatecomments,feedbackandupgradesfromthereaders, sothatcorrectionandimprovementcanbemadeforlatereditionsorprintings. xli xlii Preface TheeditorialteamisalsogratefulforthevaluablesupportfromthePublisher(John Wiley&SonsLtd.),inparticularMsLynetteJames,andfromtheProjectManager (GrayPublishing),inparticularMsLesleyGray,fortheirefficientcoordinationduring theplanning,reviewandproductionphaseofthispublicationeffort. Finally, this handbook is dedicated to all past and present residue analytical chemists. It is their vision and creativity that continues to push back the frontier ofresidueanalyticaltechnology. PhilipW.Lee Newark,Delaware December,2002 Editorial Board Editor-in-Chief DrPhilipWLee DuPontCropProtection Stine-HaskellResearchCenter Newark Delaware USA Associate Editors ProfessorHiroyasuAizawa DrAldosCBarefoot DrJohnJMurphy HiroResearchConsultancy DuPontCropProtection DietaryExposure Inc.(HRCI) Stine-HaskellResearchCenter BayerCropScience Tokyo Newark Stilwell Japan Delaware Kansas USA USA Founding Editor DrTerryRoberts Anglesey NorthWales UK List of contributors LutzAlder FederalInstituteforHealthProtectionof JohannesCorley Rutgers,TheStateUniversityofNew ConsumersandVeterinaryMedicine(BgVV),Berlin, Jersey,NorthBrunswick,NJ,USA Germany KayK.Curry TechnologySciencesGroupInc., ToddA.Anderson TexasTechUniversity,Lubbock, Washington,DC,USA TX,USA WilliamJ.Englar EnglarFoodLaboratories,Inc., ReinerBacher PTRLEuropeGmbH,Ulm,Germany MosesLake,WA,USA MichaelR.Barrett UnitedStatesEnvironmental CherylM.Englar-Coulter EnglarFoodLaboratories, ProtectionAgency,Washington,DC,USA Inc.,MosesLake,WA,USA ElizabethBehl UnitedStatesEnvironmentalProtection NealEwing NationalFoodLaboratory,Inc.,Dublin, Agency,Washington,DC,USA CA,USA KimberlyS.Billesbach BayerCropScience,Stilwell, JohnFuhrman Monsanto,St.Louis,MO,USA KS,USA RichardJ.Fussell CentralScienceLaboratory,York, JamesF.Brady SyngentaCropProtection,Inc., UK Greensboro,NC,USA WillaGarner GARNDALAssociates,Inc.,Mount DavidJ.Brookman TechnologySciencesGroupInc., Airy,MD,USA Washington,DC,USA ShirleyJ.Gee UniversityofCalifornia,Davis,CA, ThomasJ.Burnett EliLillyandCompany,Greenfield, USA IN,USA ThomasJ.Gould BayerCropScience,Stilwell,KS, MariaElenaY.Cabusas DuPontCropProtection, USA Newark,DE,USA TimothyJ.Grace BayerCropScience,Stilwell,KS, LeslieS.Carver WaterborneEnvironmental,Inc., USA Leesburg,VA,USA CharlesA.Green ValentUSACorporation,Dublin, AndreyChen FMC,Princeton,NJ,USA CA,USA JosephR.Chepega WaterborneEnvironmental,Inc., AmyHackett Monsanto,St.Louis,MO,USA Leesburg,VA,USA BruceD.Hammock UniversityofCalifornia,Davis, MihaiCicotti BattelleMemorialInstitute,Geneva, CA,USA Switzerland RalfHa¨nel FederalBiologicalResearchCentrefor ThomasJ.Class PTRLEuropeGmbH,Ulm,Germany AgricultureandForestry(BBA),Braunschweig,Germany GeorgeP.Cobb TexasTechUniversity,Lubbock,TX, VincentHebert WashingtonStateUniversity,Richland, USA WA,USA xliv Listofcontributors AndrewJ.Hewitt StewartAgriculturalResearch JamesS.LeNoir DuPontCropProtection,Newark,DE, Services,Macon,MO,USA USA RichardHoneycutt H.E.R.A.C.,Inc.,Greensboro,NC, YiLin SyngentaCropProtection,Inc.,Greensboro,NC, USA USA MitsumasaIkeda KumiaiChemicalIndustryCo.,Ltd, CynthiaLipton Byotix,Inc.,Richmond,CA,USA Shizuoka,Japan JosephH.Massey MississippiStateUniversity, YujiIkemoto NihonNohyakuCo.Ltd,Osaka,Japan Starkville,MS,USA FujioIshijima HokkoChemicalIndustryCo.Ltd, GregC.Mattern BayerCropScience,Stilwell,KS, Kanagawa,Japan USA ScottH.Jackson BASFCorporation,Research JosephP.McClory DuPontCropProtection,Newark, TrianglePark,NC,USA DE,USA KathrynM.Jernberg DuPontCropProtection, CarolynMentzer AgrisearchIncorporated,Thurmont, Newark,DE,USA MD,USA WilliamW.John DuPontCropProtection,Stine D.LarryMerricks AgrisearchIncorporated,Frederick, HaskellResearchCenter,Newark,DE,USA MD,USA SetsukoKatsurada SankyoCo.Ltd,Shiga,Japan SeanM.Moore BayerCropScience,Stilwell,KS,USA GuentherKempe Landesuntersuchungsanstalt, KoujiNakamura SaitamaPrefectureAgricultureand Chemnitz,Germany ForestryResearchCenter,Kuki,Japan DouglasE.Kiehl EliLillyandCompany,Greenfield, KazuoOgura AgriculturalChemicalsInspection IN,USA Station,Tokyo,Japan PhilipJamesKijak USFoodandDrugAdministration, JeffOld InvereskResearch,Tranent,UK Laurel,MD,USA TakeoOtsuka SankyoCo.Ltd,Shiga,Japan HirokoKobayashi ResearchInstituteofJapanPlant ProtectionAssociation,Ibaraki,Japan JohnC.Peterson EnglarFoodLaboratories,Inc., MosesLake,WA,USA AlexanderJ.Krynitsky USEnvironmentalProtection Agency,EPAEnvironmentalScienceCenter,FortMeade, BethM.Polakoff Exponent,Inc.,Washington,DC, MD,USA USA ChungK.Lam BayerCropScience,Stilwell,KS,USA CharlesR.Powley DuPontCropProtection,Newark, DE,USA StevenJ.Lehotay USDAAgriculturalResearch Service,EasternRegionalResearchCenter,Wyndmoor, RobinS.Readnour EliLillyandCompany,Greenfield, PA,USA IN,USA WilliamM.Leimkuehler BayerCropScience,Stilwell, ValerieB.Reeves USFoodandDrugAdministration, KS,USA Rockville,MD,USA Listofcontributors xlv StewartL.Reynolds CentralScienceLaboratory,York, GuyR.Stehly USGS,BiologicalResourcesDivision, UK LaCrosse,WI,USA NeilJ.Robinson Syngenta,Bracknell,UK ShigejiSugimoto NipponSodaCo.Ltd,Tokyo,Japan JanineE.Rose PTRLWest,Inc.,Hercules,CA,USA ManabuToujigamori SankyoCo.Ltd,Shiga,Japan LouisRusso BayerCropScience,KansasCity,MO, YasuhiroTsujino SankyoCo.Ltd,Shiga,Japan USA MichaelP.Turberg EliLillyandCompany,Greenfield, MarikoSabi SankyoCo.Ltd,Shiga,Japan IN,USA TakashiUeda SankyoCo.Ltd,Shiga,Japan ShingoSadakane SankyoCo.Ltd,Shiga,Japan MasakoUeji NationalInstituteforAgro-Environmental ManasiSaha BASFCorporation,ResearchTriangle Sciences,Tsukuba,Japan Park,NC,USA NoriharuUmetsu OtsukaChemicalCo.Ltd,Naruto, TakashiSaito SankyoCo.Ltd,Shiga,Japan Japan YoshihiroSaito KumiaiChemicalIndustryCo.,Ltd, DavidL.Valcore DowAgroSciences,Indianapolis,IN, Shizuoka,Japan USA ThomasSchreier ValentUSACorporation,Dublin, ChantelVanBellinghan Monsanto,Brussels,Belgium CA,USA MichaelF.Wilson CentralScienceLaboratory,York, JamesN.Seiber WesternRegionalResearchCenter, UK USDAAgriculturalResearchService,Albany,CA,USA JamesE.Woodrow UniversityofNevada,Reno,NV, RobertJ.Seymour BayerCropScience,Research USA TrianglePark,NC,USA AkiraYagi KumiaiChemicalIndustryCo.,Ltd, GuominShan DowAgroSciencesLLC,Indianapolis, Shizuoka,Japan IN,USA KatsuraYagi OtsukaChemicalCo.Ltd,Naruto, WeilinL.Shelver USDepartmentofAgriculture, Japan AgriculturalResearchService,Fargo,ND,USA HisayoshiYamagishi ResearchInstituteofJapanPlant JohannesSiebers FederalBiologicalResearchCentre ProtectionAssociation,Ibaraki,Japan forAgricultureandForestry(BBA),Braunschweig, Germany HirokiYamamoto ShimaneUniversity,Matsue, Japan DavidJ.Smith USDepartmentofAgriculture, AgriculturalResearchService,Fargo,ND,USA RobertA.Yokley SyngentaCropProtection,Inc., Greensboro,NC,USA CraigA.Smitley Scynexis,ResearchTrianglePark, NC,USA SabrinaX.Zhao PfizerInc.,Groton,CT,USA LisaD.Spurlock-Brouwer EliLillyandCompany, EberhardZietz InstitutFresenius,Taunusstein, Greenfield,IN,USA Germany Contents of Volume 1 Preface xli Listofcontributors xliii Introduction JamesN.Seiber 1 Introduction 1 Relationshipofpesticideresidueanalysis,regulation,andriskassessment 4 Whodoesresidueanalysisandwhy 5 Challenges 7 References 8 Regulatoryguidanceandscientificconsiderationforresidue analyticalmethoddevelopmentandvalidation Assessmentofresidueanalyticalmethodsforcrops,food,feed,and environmentalsamples:theapproachoftheEuropeanUnion JohannesSiebersandRalfHa¨nel 13 Introduction 13 Legalbackground 14 General 14 CouncilDirective91/414/EEC 14 LegislationrelatedtoMRLs 15 Legislationrelatedtoresidueslimitsforsoil,water,andair 18 Provisionsforresidueanalyticalmethods 18 Evaluationofthesubmittedmethods 20 Institutionalbackground 20 Validationparameters 21 Requirementsforpost-registrationandmonitoring(enforcement)methods 23 Generalrequirements 23 Specificrequirements 27 Requirementsfordatagenerationmethods 31 Generalrequirements 32 Specificrequirements 33 Availabilityofanalyticalmethods 34 Perspectives 35 Acknowledgement 36 References 36 v vi ContentsofVolume1 Regulatoryconsiderationsforresidueanalysisandmethodsoncropsandfood: theapproachofJapan KazuoOgura,HisayoshiYamagishiandShigejiSugimoto 38 Background 38 Plantmetabolismstudies 40 Residuestudiesoncrops 41 Residueanalyticalmethod 41 Preferredmethodologyforconductingsupervisedfieldtrials 41 Fielddata(fieldreport)presentation 46 Extrapolationamongtheformulationtypes 47 Residuedefinition 47 MarketbasketsurveyinJapan 48 Conclusion 49 Furtherreading 49 Generalapproachesforresidueanalyticalmethoddevelopmentandvalidation ThomasJ.ClassandReinerBacher 50 Introduction 50 Approachestoanalyticalmethoddevelopment 51 Propertiesoftheanalyte(s) 51 Functionalgroupsoftheanalyte(s) 52 Propertiesofthesamplematerial 53 Availabilityandpracticalityofanalyticalinstrumentation 54 Considerationoftime,throughput,ruggednessandquality 54 Practicalexamples 55 Extendingthescopeofthemulti-residuemethodDFGS19 55 Whatcangowrong? 57 Beyondthelimits 58 References 58 Bestpracticesinestablishingdetectionandquantificationlimitsforpesticide residuesinfoods JohannesCorley 59 Introduction 59 Definitions 61 MethodsfordefiningLODandLOQ 63 IUPACmethod 63 Propagationoferrorsmethod 66 Hubaux–Vosapproach 67 Two-stepapproach(proposedbytheUSEPA) 67 RMSEmethod 68 Thet s method 70 99 LLMV Confirmation 71 Representativedata 72 Conclusions 73 Acknowledgements 74 References 74
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